FDA 510(k) Application Details - K960356

Device Classification Name Ring, Annuloplasty

  More FDA Info for this Device
510(K) Number K960356
Device Name Ring, Annuloplasty
Applicant THE HEART VALVE DIV. MEDTRONIC CARDIOVASCULAR SURG
18011 SOUTH MITCHELL
IRVINE, CA 92714 US
Other 510(k) Applications for this Company
Contact KATHLEEN T BOEHM
Other 510(k) Applications for this Contact
Regulation Number 870.3800

  More FDA Info for this Regulation Number
Classification Product Code KRH
Other 510(k) Applications for this Device

  More FDA Info for this Product Code
Date Received 01/25/1996
Decision Date 08/27/1996
Decision ST - Substantially Equivalent - Subject to Tracking Reg.
Classification Advisory Committee CV - Cardiovascular
Review Advisory Committee CV - Cardiovascular
Statement / Summary / Purged Status
Type Traditional
Reviewed By Third Party N
Expedited Review



Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact